Perioperative Interdisciplinary, Intersectoral Process Optimization in Heart Failure
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Giessen
About this trial
Chronic heart failure affects up to three million people in Germany, with prevalence increasing with age. It is a leading cause of cardiovascular disease-related deaths. Patients with heart failure undergoing non-cardiac surgery face higher risks of complications and death compared to those with coronary artery disease. Despite guidelines recommending comprehensive preoperative evaluation, there is no systematic risk assessment structure in place, leading to inadequate perioperative care. This study aims to evaluate a multidisciplinary approach for high-risk patients aged 65 and above, regardless of prior heart failure diagnosis, to mitigate postoperative complications. The investigators measure the NTpro BNP before surgery and include patients with NTproBNP\> 450 in this study and randomize them either to the standard care group or the intervention group.The hypothesis is that standardized risk screening and multidimensional care (Intervention group) can reduce complications in these patients undergoing non-cardiac surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 65 years
Elective non-cardiac surgical operation with intermediate or high operative risk under general anesthesia or combined anesthesia (general and regional anesthesia) as per Figure 1
ASA (American Society of Anesthesiologists) grade ≥ II
Qualification for randomization: NT-proBNP ≥ 450pg/ml during routine preoperative evaluation and anesthesia consultation.
Disqualifiers
Age < 65 years
Cardiac surgery and cardiology interventional procedures
Transplantation surgery (e.g., kidney, liver, lung transplantation)
Kidney surgery (e.g., nephrectomy, partial nephrectomy)
Trial design
Design model
Parallel
Treatments tested in this trial
Interdisciplinary decision-making for perioperative care
Other interventionInterdisciplinary decision-making for perioperative care involving a cardiologist, anesthesiologist, and surgeon in collaboration with the primary care physician. Decisions include determining whether surgery is feasible or if patient optimization is necessary first. Subsequently, targeted postoperative visits by a heart failure nurse and appropriate postoperative care, also after discharge from the hospital, through the primary care physician.
Treatment groups
1,057 Participants
are divided into 2 treatment groupsGroup A: Standard groupNo intervention 0 interventions
Group B: Intervention groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
combined primary endpoint at 90 days post-operation : re-hospitalization,AKI, bacterial infection and cardiac decompensation
The combined primary endpoint at 90 days post-operation consists of re-hospitalization for any reason, acute kidney injury according to KDIGO definition, any bacterial infection, and cardiac decompensation.
Time frame
90 days post-operationSecondary outcomes
1
Incidence of acute kidney injury
Indicidence of acute kidney injury based on KDIGO classification, Stage 1,2,3
Time frame
at 30 and 90 days2
Incidence of any, treatable, suspected, or confirmed bacterial infection
Incidence of any, treatable, suspected, or confirmed bacterial infection
Time frame
at 30 and 90 days3
Incidence of cardiac decompensation
Incidence of cardiacx decompensation including lung edema, peropheral edema, dyspnoe, pleural effusion
Time frame
at 30 and 90 days4
Incidence of re-hospitalization
Incidence of re-hospitalization
Time frame
at 30 and 90 daysOther outcomes
1
Utilization of services and costs
Utilization of services and costs of each patient during the hospital stay
Time frame
during the intervention at the hospitalSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Giessen
Lead sponsor
Deutsche Luft und Raumfahrt
Collaborator
Source ClinicalTrials.gov